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Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent

This study has been terminated.
(Discontinued PB127 development program for business reasons)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584714
First Posted: January 2, 2008
Last Update Posted: July 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Point Biomedical
  Purpose
The purpose of this study is to collect longer term follow-up information concerning health and survival on selected patients who received PB127 for injectable suspension in the pivotal trial (127-014).

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-Term Follow-Up of Selected Patients Enrolled in Phase 3 Clinical Trial 127-014 Using PB127 Ultrasound Imaging Agent

Further study details as provided by Point Biomedical:

Primary Outcome Measures:
  • To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014 [ Time Frame: 1 year ]

Estimated Enrollment: 300
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with low/very low pre-test probability of coronary artery disease enrolled in Protocol 127-014 who did not have or were not schedule to undergo coronary angiography at the time of enrollment and did not have a clinical outcome during the initial 6 month follow-up period.
Criteria

Inclusion Criteria:

Patients enrolled in Protocol 127-014 who

  1. Were enrolled in Stratum 1
  2. Did not undergo angiography during study evaluation
  3. Did not have a clinical oucome during the initial 6 month follow-up period as described in Protocol 127-014.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584714


  Show 39 Study Locations
Sponsors and Collaborators
Point Biomedical
Investigators
Study Director: Alexander Ehlgen, MD, PhD POINT Biomedical Corp.
  More Information

Responsible Party: Tom Ottoboni PhD/Chief Operating Officer, POINT Biomedical Corp.
ClinicalTrials.gov Identifier: NCT00584714     History of Changes
Other Study ID Numbers: 127-014-A
First Submitted: December 20, 2007
First Posted: January 2, 2008
Last Update Posted: July 3, 2008
Last Verified: July 2008

Keywords provided by Point Biomedical:
ultrasound
perfusion
SPECT
coronary artery disease
chest pain
low probability
angiography
clinical outcomes

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases